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Study of Durvalumab with Radiation Therapy for Patients with Early Stage Non-Small Cell Lung Cancer and Osimertinib for Those with EGFR Mutation

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying treatments for patients with early-stage non-small cell lung cancer (NSCLC), a type of lung cancer that is not small cell in nature. The study involves two main treatments. The first treatment is with a medication called durvalumab, also known by its code name MEDI4736, which is given alongside a type of radiation therapy called stereotactic body radiation therapy (SBRT). The second treatment involves a medication called osimertinib, also known as AZD9291, which is given after radiation therapy to patients whose cancer has a specific change in the EGFR gene, making it more sensitive to this treatment.

The purpose of the study is to evaluate how effective these treatments are in managing early-stage NSCLC. For the durvalumab group, the study will compare the effects of durvalumab combined with SBRT to a placebo combined with SBRT. For the osimertinib group, the study will assess the effects of osimertinib following SBRT in patients with an EGFR mutation. The study will follow participants over a period to observe the progression of the disease and overall survival rates.

Participants in the study will receive either the active treatment or a placebo, depending on the group they are in. The study will involve regular monitoring and assessments to track the progress of the disease and any side effects from the treatments. The study aims to provide valuable information on the effectiveness of these treatments in improving outcomes for patients with early-stage NSCLC.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will provide signed and dated written informed consent before any study-specific procedures, sampling, and analyses begin.

    Eligibility criteria include being 18 years or older, having a confirmed diagnosis of Stage I/II non-small cell lung cancer (NSCLC), and planning to receive stereotactic body radiation therapy (SBRT) as definitive treatment.

  2. Step 2

    Initial assessments

    Initial assessments will include staging studies such as a PET-CT scan within 10 weeks of screening.

    Pulmonary function testing will be conducted within 16 weeks of randomization for the main cohort.

  3. Step 3

    Treatment phase for main cohort

    Patients in the main cohort will receive durvalumab administered intravenously as a solution for infusion.

    The treatment will be combined with standard of care (SoC) SBRT.

  4. Step 4

    Treatment phase for osimertinib cohort

    Patients in the osimertinib cohort will receive osimertinib orally in the form of film-coated tablets.

    This treatment follows the completion of SoC SBRT.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, patients will undergo regular monitoring, including laboratory studies, clinical evaluations, and electrocardiograms (ECG).

    The study will assess progression-free survival (PFS) and overall survival (OS) as primary and secondary endpoints.

  6. Step 6

    End of study

    The estimated end date for the study is January 30, 2028.

    Patients will continue to be monitored for safety and efficacy outcomes until the study concludes.

Who can join the trial?

15 criteria

  • You must provide a signed and dated written consent form before any study-specific procedures, sampling, and analyses.
  • You need to be at least 18 years old.
  • You should have Stage I or II Non-small Cell Lung Cancer (NSCLC) that is documented through a biopsy or cell sample. The cancer should be at a specific stage (T1 to T3N0M0) and planned to be treated with a type of radiation therapy called **Stereotactic Body Radiation Therapy (SBRT)**.
  • You should be planned to receive **SBRT** as the main treatment.
  • Your overall health should be good enough to perform daily activities, as measured by a scale called the **World Health Organization (WHO)/ECOG Performance Status**, with a score of 0, 1, or 2.
  • You can have either central or peripheral lung lesions.
  • If you have had another type of lung cancer in the past or have multiple lung lesions at the same time, you may still be eligible, with some exceptions.
  • You must have certain tests done during the screening process, including a **PET-CT scan** within 10 weeks.
  • You need to submit available tumor tissue or cell samples from a procedure called **Fine Needle Aspiration (FNA)**.
  • For the main cohort (durvalumab), you should have a life expectancy of at least 12 weeks.
  • For the main cohort (durvalumab), you should weigh more than 30 kg (about 66 pounds).
  • For the main cohort (durvalumab), your organs and bone marrow should be functioning well enough.
  • For the main cohort (durvalumab), you need to have a **Pulmonary Function Test** within 16 weeks of being assigned to a treatment group.
  • For the osimertinib cohort, your tumor must have one of the two common **EGFR mutations** that make it sensitive to a type of treatment called **EGFR-TKI**. These mutations are known as **Ex19del** or **L858R**.
  • For the osimertinib cohort, you should have enough bone marrow reserve or organ function.

Who cannot join the trial?

6 criteria

  • Patients who have had surgery to remove their lung cancer cannot participate.
  • Patients with lung cancer that has spread to the lymph nodes are not eligible.
  • Patients with lung cancer that has spread to other parts of the body are excluded.
  • Patients who do not have a specific type of genetic change in their cancer called a sensitizing EGFR mutation cannot join the osimertinib group. This mutation is a change in the DNA that can affect how cancer grows.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, meaning they might need special protection or care, are not eligible.
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Investigated drugs

  • Durvalumab

    is a medication used in this trial to help the body's immune system fight cancer. It is being tested in combination with a type of radiation therapy called Stereotactic Body Radiation Therapy (SBRT) to see if it can improve outcomes for patients with certain types of lung cancer that cannot be removed by surgery.

  • Osimertinib

    is another medication being studied in this trial. It is used for patients with a specific genetic mutation in their lung cancer. The trial is testing if taking osimertinib after receiving SBRT can help prevent the cancer from coming back over a period of four years.

What is already known about the treatment

  • Durvalumab

    Durvalumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently being studied in clinical trials for its effectiveness in treating patients with unresected Stage I/II, lymph-node negative Non-small Cell Lung Cancer (NSCLC). The main therapeutic indication is to improve progression-free survival in these patients. At the molecular level, durvalumab works by blocking the PD-L1 protein, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor.

  • Osimertinib

    Osimertinib is taken orally in tablet form. It is being investigated in clinical trials for patients with unresected Stage I/II, lymph-node negative NSCLC that have a specific EGFR mutation. The primary therapeutic use is to enhance progression-free survival following standard care stereotactic body radiation therapy. Osimertinib functions by inhibiting the activity of the EGFR tyrosine kinase, which is involved in the growth and spread of cancer cells. It is classified as a tyrosine kinase inhibitor.

Investigated diseases

Non-small Cell Lung Cancer – Non-small Cell Lung Cancer (NSCLC) is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It is characterized by the uncontrolled growth of cells in the tissues of the lung. NSCLC is often diagnosed at an advanced stage because early stages may not present noticeable symptoms. As the disease progresses, it can spread to other parts of the body, including lymph nodes and distant organs. The progression of NSCLC is typically categorized by stages, with Stage I and II indicating localized cancer without lymph node involvement. The presence of specific genetic mutations, such as EGFR mutations, can influence the behavior and progression of the disease.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-512667-31-00Protocol codeD9103C00001Estimated enrolment690 patientsSponsorAstraZeneca AB

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